F.D.A. Reports Reduced Risks With Condoms

By GARDINER HARRIS

Published: November 11, 2005

Used correctly, latex condoms greatly reduce the risks of pregnancy and disease, the Food and Drug Administration said Thursday in a 63-page report.

Prepared in response to a five-year-old law, the report is to form the basis for labels for condom packaging and provide more up-to-date information about effectiveness.

The federal drug regulators found that latex condoms are ''highly effective'' at preventing infection by H.I.V., gonorrhea, chlamydia, trichomoniasis and hepatitis B, largely because all of these diseases are spread through penile contact.

But the agency noted that condoms seem to be less effective against genital herpes, human papillomavirus, syphilis and chancroid because lesions from these diseases may appear on skin not covered by condoms, the report said.

Protection against human papillomavirus, which can cause cervical cancer, ''is partial at best,'' it stated. Still, condoms provide some protection against each of these diseases, the F.D.A. concluded. Also, the report said, ''These studies show that the typical pregnancy rate after six months' reliance on condoms is 5.4 percent to 7.9 percent.''

But Senator Tom Coburn, the Oklahoma Republican who sponsored the legislation that produced the report, immediately criticized its contents.

''Today's misleading recommendations by the F.D.A. are the latest example where the agency has put the public at risk by providing inaccurate information about condoms,'' said Mr. Coburn, a physician who has said that condom labels provide exaggerated and dangerous reassurance that condoms protect against sexually transmitted disease.

Mr. Coburn said the Food and Drug Administration had not required condom manufacturers to conduct clinical trials.

The F.D.A. has often become the focal point of battles involving abortion and reproductive politics. In recent months, an intense battle has erupted over its delay in deciding whether Plan B, an emergency contraceptive pill, should be allowed to be sold over the counter. The agency's approval in 2000 of an abortion pill enraged abortion opponents.

That same year, Mr. Coburn, as a House member, sponsored the legislation requiring the agency to reassess condom labels.

Mr. Coburn and Representative Mark Souder, Republican of Indiana, complained that the agency overstated condoms' protection against the virus that causes cervical cancer.

''This dangerous assurance overlooks the fact that condoms will not protect a user from contracting or spreading the sexual disease to others,'' Mr. Souder said in a statement.

The report also discusses the risks and benefits of condoms that use as a lubricant the spermicide Nonoxynol-9. Studies suggest that this spermicide may increase the risks of infection by sexually transmitted diseases because it irritates vaginal and anal skin, the report said.